Pharmaceutical Jobs in Usa

In this role, you will report to the Hiring Manager and will work closely with the Avantor's Advanced Laboratory Services professionals to serve our customers by performing customized, mission-based lab work and research protocols that help return time back to science.

Location:Springhouse, PA

Schedule:Monday - Friday 7 am - 3:30 pm

Hourly Rate:$20.30

Benefits:

• Health and Wellness: Medical, Dental, Vision, and Wellness programs (eligible for medical coverage on day 1)

• Time Off: Paid Time Off (PTO), company-paid holidays, Choice holidays, etc.

• Financial Well Being: Spending Accounts: Flexible Spending Account (FSA), Health Savings Accounts (HSA), commuter benefits, 401(k), tuition assistance, employee stock purchase plan discount

• Added Protection Coverage: To include critical illness, hospital indemnity, accident, legal, identity theft protection, pet, auto, and home insurance

• Recognition: Celebrate your peers and earn points to redeem for gifts and products.

What we're looking for

Education:High School Diploma or GED required

Experience:1-2 years of experience in a customer-facing or laboratory environment.

Collaboration Tool:Knowledge of Information, intermediate computer skills, including Microsoft Office, with proficiency in Word and Excel

Preferred Qualifications:

• Conform to all customer requirements for background checks, health and safety issues, security clearances, and medical checkups

• Requires knowledge in using various instruments to prepare for and perform tests

• Excellent Customer Service Skills; display a professional can-do attitude

• Perform duties with the highest regard for safety and quality

• Ability to understand and follow site protocols, policies, and procedures

• Must be flexible, forward-thinking, motivated, and have the ability to act independently

• Must be able to lift 25 lbs

How you will thrive and create an impact

Avantor's Advanced Laboratory Services team is a crucial part of the Avantor Services group serving over 500 customers in biopharma, pharmaceutical, educational, industrial, and high-tech industries with customizable, flexible solutions and end-to-end laboratory operations support.

• Complete routine laboratory procedures, such as but not limited to preparation of solvents, buffers, resins, reagent solutions, media prep, mixing of chemicals, etc.

• Report timely and accurate test results according to laboratory policies and procedures.

• Routine maintenance of lab equipment and troubleshooting.

• Store chemicals properly, dispose of chemical waste, adhere to safety procedures, and participate in safety programs.

• Manage inventory, maintain processes, and order laboratory supplies, including glassware and chemicals for biotech/pharmaceutical processes.

• Maintain records utilizing electronic laboratory notebooks (eLNs).

• Maintain files, track orders, and process shipping requests.

• Track and document chemical usage and inventory.

• Restocking glassware and chemicals.

• Maintain a clean room to prevent contamination and maintain the integrity of production.

• Calibrate balances and pH meters.

• Inspect laboratory safety stations.

• Perform other duties as assigned.

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.

We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Know Your Rights poster.

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.

In this role, you will report to the Site Manager and will work closely with the Avantor's Advanced Laboratory Services professionals to serve our customers by performing customized, mission-based lab work and research protocols that help return time back to science.

Location: Rockville, MD

Shift: Mon - Fri, 8:30 am -5:00 pm

Hourly Range: $25 -$26

Benefits:

• Health & Wellness: Medical, Dental, Vision, and Wellness programs.

• Time Off: PTO, company-paid holidays, choice holidays.

• Financial Well-Being: FSA, HSA, commuter benefits, 401(k), tuition assistance, employee stock purchase plan.

• Added Protection: Critical illness, accident, legal, identity theft, pet, auto, and home insurance.

• Recognition: Earn points to redeem for gifts and products.

What we're looking for

Education: Bachelor's degree or equivalent work experience required.

Experience:

Minimum 2+ years in lab operations required

2 years of hands-on experience in histology and microtomy, including precise tissue sectioning required

Technical Skills:

• Microsoft Teams and Office Suite proficiency.

• Knowledge of lab equipment maintenance and safety protocols.

• Familiarity with inventory systems and KPI reporting.

Preferred Certifications:

• SHE safety training

• Hazardous materials handling (IATA/DOT)

• Lab operations or equipment maintenance certifications

How you will thrive and create an impact

Avantor's Advanced Laboratory Services team is a crucial part of the Avantor Services group serving over 500 customers in biopharma, pharmaceutical, educational, industrial, and high-tech industries with customizable, flexible solutions and end-to-end laboratory operations support. In this role you will:

Laboratory Operations & Support

• Perform routine laboratory procedures such as media and buffer preparation, reagent/solvent mixtures, filtrations, material weighing, and basic physical testing.

• Support senior staff by preparing materials and assisting with experiments.

• Maintain and verify laboratory equipment (e.g., balances, pH meters).

• Manage inventory and labeling of chemicals, glassware, and gas cylinders.

• Executed routine histology and microtomy procedures utilizing instruments such as rotary microtomes, cryostats, paraffin embedding systems, tissue processors, and automated slide stainers.

Sample Management

• Receive and check in samples using manual or electronic tracking systems.

• Assign proper storage locations and maintain accurate storage records.

• Complete and maintain all paperwork associated with sample deliveries.

• Prepare, secure, and package samples for shipment; document contents for manifests.

• Coordinate with shipping/receiving teams to schedule and stage outbound items.

Material Management - Human Biological Samples (HBS)

• Handle Human Biological Samples in accordance with biosafety protocols, privacy standards, and ethical guidelines.

• Label and accession HBS into the Laboratory Information Management System (LIMS).

• Manage HBS disposal following established processes.

• Operate and maintain HBS storage systems, including -80C freezers, -180C liquid nitrogen freezers, and ambient storage cabinets.

• Maintain documentation, tracking, and inventory accuracy related to HBS and associated storage equipment.

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.

We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

Pay Transparency:

The expected pre-tax pay for this position is

Actual pay may differ depending on relevant factors such as prior experience and geographic location.

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Know Your Rights poster.

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.

In this role, you will report to the Territory Area Manager and will work closely with the Avantor's Advanced Laboratory Services professionals to serve our customers by performing customized, mission-based lab work and research protocols that help return time back to science.

Location: Cambridge, MA

Shift: Monday - Friday 7:30 AM - 4:00 PM

Hourly pay range: $24 - $27

Benefits:

Health & Wellness

• Comprehensive Medical, Dental, and Vision coverage

• Wellness programs

• Eligible for medical coverage starting Day 1

Time Off

• Paid Time Off (PTO)

• Company-paid holidays

• Choice holidays

Financial Well-Being

• Flexible Spending Account (FSA) and Health Savings Account (HSA)

• Commuter benefits

• 401(k) retirement plan

• Tuition assistance

• Employee Stock Purchase Plan discount

What we're looking for

Education:

• High school diploma or GED required

• Bachelor's degree preferred

Experience:

• Minimum 2 years in customer service, inventory replenishment, or material handling

• 1-2 years of experience in a laboratory environment or familiarity with lab processes and procedures preferred

• 1-2 years of experience

Technical Skills:

• Proficient in Microsoft Office and comfortable using computers

• Experience with Microsoft Teams preferred

• Knowledge of SAP, Oracle, Power BI, and other inventory management systems

Additional Requirements:

• Ability to lift up to 25 lbs

• Previous experience in a GMP-regulated facility strongly desired

• Strong communication skills

How you will thrive and create an impact

Avantor's Advanced Laboratory Services team is a crucial part of the Avantor Services group serving over 500 customers in biopharma, pharmaceutical, educational, industrial, and high-tech industries with customizable, flexible solutions and end-to-end laboratory operations support. In this role you will:

Glassware Washing & Laboratory Support

• Perform routine washing, drying, and sterilization of laboratory glassware following established SOPs.

• Inspect glassware for cleanliness, damage, or wear and remove items that do not meet quality standards.

• Organize, label, and restock clean glassware to designated laboratory areas to ensure uninterrupted workflow.

• Maintain cleanliness of washing stations, autoclaves, drying ovens, and related equipment.

• Track inventory of glassware and notify appropriate personnel of low stock or replacement needs.

PPE Cleaning & Maintenance

• Collect, clean, and sanitize personal protective equipment (PPE) according to facility hygiene and safety requirements.

• Inspect PPE for damage, contamination, or wear and escalate issues requiring replacement.

• Ensure all cleaned PPE meets quality and safety standards prior to restocking or redistribution.

PPE Restocking & Inventory

• Monitor PPE inventory levels and restock gowns, gloves, eyewear, lab coats, and other protective items across designated labs or workstations.

• Maintain accurate inventory logs and communicate supply needs to procurement or site leads.

• Ensure PPE stations remain organized, labeled, and accessible to laboratory personnel.

Buffer Preparation

• Assist with preparing laboratory buffers and solutions following established formulations and SOPs.

• Measure, mix, and label chemical components clearly and accurately.

• Perform pH adjustments, verify concentrations, and maintain batch documentation.

• Ensure proper storage and handling of prepared buffers to maintain stability and compliance.

Chemical Management

• Support safe handling, storage, and organization of laboratory chemicals.

• Track chemical inventory and assist with ordering, receiving, and restocking materials.

• Maintain up-to-date SDS files and support chemical safety compliance.

• Assist with waste collection, labeling, and disposal following environmental and regulatory guidelines.

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.

We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Know Your Rights poster.

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.

• 
  
• Bachelor's degree in science, healthcare, communications, or a related field, or equivalent work experience.
  
• Strong editorial and proofreading experience.
  
• Experience reviewing regulated content, preferably in pharmaceutical, healthcare, or medical environments.
  
• Exceptional attention to detail and quality control skills.
  
• Strong written and verbal communication skills.
  
• Ability to collaborate with cross-functional teams and external agencies.
  
• Comfort working within structured review and approval workflows.
  

• 
  
• Medical editing experience within pharmaceutical, biotech, healthcare, or medical communications environments.
  
• Knowledge of the AMA Style Guide.
  
• Experience reviewing promotional or marketing materials in regulated industries.
  
• Experience using Veeva Promomats or similar content approval systems.
  
• Familiarity with FDA advertising and promotional submission processes would be ideal.
  

• 
  
• Review and edit promotional, non-promotional, and internal materials to ensure accuracy, clarity, and consistency.
  
• Perform quality control checks on materials prior to routing them through the approval workflow.
  
• Ensure materials adhere to editorial standards, regulatory guidelines, and style conventions, including the AMA Style Guide when applicable.
  
• Identify necessary edits or revisions and clearly communicate feedback to stakeholders.
  
• Support regulatory and QC reviews during the approval process.
  

• 
  
• Coordinate the review and approval process for marketing and promotional materials.
  
• Maintain knowledge of approval routing processes and SOP requirements and ensure materials are routed appropriately.
  
• Facilitate PRC (Promotional Review Committee) meetings, including preparing agendas, documenting discussions, and capturing meeting outcomes.
  
• Support final approvals, re-approvals, and other review types as required.
  

• 
  
• Work closely with marketing teams, agencies, regulatory teams, and other stakeholders throughout the approval process.
  
• Communicate required edits, feedback, and changes clearly and efficiently.
  
• Partner with marketing operations teams to prioritize review workflows, especially during major campaign launches or label updates.
  

• 
  
• Manage workflows within Veeva Promomats or similar electronic review systems.
  
• Maintain user profiles, training access, and permissions for sponsors, agencies, and reviewers within the system.
  
• Serve as a point of contact for system maintenance and optimization in collaboration with vendors and IT teams.
  
• Assist with system validation activities related to workflow tools.
  

• 
  
• Support FDA Ad Promo submission processes, including preparation of Form 2253 and related documentation.
  
• Coordinate submission materials and collaborate with regulatory operations teams.
  
• Archive regulatory correspondence according to compliance guidelines.
  

• 
  
• Generate workflow and system metrics reports to support process improvements and compliance monitoring.
  
• Contribute to the development and updates of departmental procedures and work instructions.
  
• Develop and maintain training resources related to the review process and workflow tools.
  
• Train internal teams, agencies, and reviewers on editorial workflows and system usage.
  

• 
  
• Promotional and advertising content
  
• Marketing campaign materials
  
• Internal training decks and presentations
  
• Educational and informational materials
  
• Internal communications and resources used by internal teams
  

• 
  
• Pharmaceutical or biotech companies.
  
• Advertising Agencies supporting regulated healthcare clients.
  

Global Project Manager - Ophthalmology

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Global Project Manager (GPM) is critical to the successful conduct of Biopharmaceutical -sponsored clinical trials as a matrix leader of the core project team. The GPM is responsible for the successful delivery of a Biopharmaceutical project(s). The GPM will be client-facing and serve as the internal lead of the project through the life cycle of the study, ensuring effective project delivery in agreement with contracted project timeline and budget. The GPM directs project delivery by driving team and financial efficiency, work product quality, and is responsible for client satisfaction through relationship management.

• May serve as a primary lead for project bids and multi trial initiatives.
• Ensures that deliverables for assigned project(s) are completed according to the contract budget, schedule, and quality standards. Effectively manages projects in all areas of performance.
• Develops effective working relationships with clients, executive management, and project staff. Collaborates with stakeholders to manage project issues, proactively identify and mitigate risks and drive milestone achievement.
• Serves as the primary point of contact for biopharma clients. Demonstrates proficiency in knowledge and understanding of client needs.
• Tracks project deliverables against contract using Emmes' tools. Proactively prepares/presents study metrics to maintain transparency for internal/external stakeholders. Monitors trends and drives changes to the plan as needed; identifies risks to delivery and collaborates with the project team to develop mitigation plans to be presented to the client.
• Ensures adherence to quality control expectations and milestone timelines for delivery of contractually required reports and deliverables.
• Manages project resources (i.e., budget, personnel, and subcontracts).
• Identifies and manages change to scope and requests for out-of-scope activities. Collaborates with Business Development, the Contracts Team, and executive management to ensure timely execution of contract amendments/change orders. Prospectively manages client expectations.
• May present in bid defense meetings in collaboration with Business Development.
• Develops study management plans in collaboration with core project team members.
• Identifies and documents lessons learned from study successes and challenges to promote development of best practices.
• Models and propagates Emmes' commitment to a culture of quality in all aspects of our deliverables, utilizing a solution-based, science-driven, value-added approach in collaborating with clients.
• Performs other duties as assigned.

• Bachelor's degree in a scientific discipline.
• Minimum 8 years demonstrating scientific principles appropriate in managing a clinical research portfolio including multi-phase research experience in a broad range of indications and client types.
• At least 3 years working in a pharmaceutical and/or CRO setting, serving in a global Trial Team Lead or Global Project Management role or equivalent position.
• Minimum of 2 years of experience in Ophthalmology clinical trials, 5 years of experience preferred.
• Demonstrable track-record of success delivering complex/ high priority clinical trials within agreed time, quality and cost working across multiple therapeutic areas, phases 1-4, in a global capacity.
• Demonstrated experience in developing and fostering client and internal relationships.
• Thorough understanding of ICH GCP and applicable global regulatory regulations and
  guidelines.
• Skilled in MS Office Suite of products and working knowledge of Clinical Trial Management Systems, electronic Trial Master File, and electronic Data Capture systems and solutions.
• Successful record in managing diverse staff and leading strong teams.
• Strong verbal and written communication skills.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Job Description:

This position supports Patient Data Intake (PDI) organization to achieve its mission of improving patient lives through consistent and accurate delivery of high quality, relevant, and timely adverse event and product quality management by providing effective oversight of external providers of Pharmacovigilance services.

Major Responsibilities:

Core job requirements include:

* Conducting oversight of vendors who identify and collect adverse event information and complete intake of Pharmacovigilance safety reports in Safety System.

Conducting oversight of vendors who identify and collect product quality complaint information and complete intake of Product Quality reports in Product Quality System.

* Conducting oversight of vendors to ensure collection, assessment, and processing of adverse event and product quality complaint information is performed in a compliant and timely manner to comply with global regulations.

* Supporting the business strategy of assisting internal and external customers in collecting information for product safety reports and products complaints related to products.

* Conducting oversight of vendors to ensure company standards for quality, compliance and productivity are met. Remaining current on knowledge and skills required for supporting customers.

* Supporting vendor case quality and productivity metrics by exhibiting the core leadership attributes: Agile and Accountable; Clear and Courageous; Make Possibilities Real; All for One ; Decide Smart and Sure.

* Supporting and participating in audits and inspections as needed.

* Supporting development of materials and delivering training in conjunction with the vendor, including train-the-trainer, special-topics, refresher, and internal trainings as needed.

* Conducting oversight to ensure the vendor is effectively communicating using various mediums and establishing rapport with customers, colleagues, and interdepartmental groups.

* Conducting oversight in the vendors use of multiple databases to document adverse event and product complaint information.

* Supporting implementation of strategies to enhance PDI excellence in providing the highest level of customer experience.

* Acting as an adverse event and product complaint intake subject matter expert.

* Gaining knowledge and expertise to initiate mentoring opportunities of other specialists in PDI.

* Participating in projects/assignments in coordination with management.

* Gaining knowledge and expertise to initiate mentoring opportunities of other specialists in PDI.

* Participating in projects/assignments in coordination with management.

* Other duties may be assigned based on the need or work requirements of the organization.

Experience/Skills:

Bachelor's degree with related health sciences background. Nursing or Pharmacy preferred

3-6 years clinical healthcare and previous pharmaceutical industry experience. Pharmaceutical industry contact center experience preferred

Provides medical support with emphasis on the intake of medical product experiences and processing standard communication requests. Acts as a liaison with Quality Assurance for product quality problems where an adverse event is involved. Works with Customer Service to provide standard information and product replacement as necessary. Provides assistance to the medical and lay community with standard information that is from the package insert or information from the standard letter database that deals with labeled and specific off-label information/indications.

Experience Level = 3-5 Years

About Us

Clayco is a full-service, turnkey real estate development, master planning, architecture, engineering, and construction firm that safely delivers clients across North America the highest quality solutions on time, on budget, and above and beyond expectations. With $7.6 billion in revenue for 2024, Clayco specializes in the "art and science of building," providing fast track, efficient solutions for industrial, commercial, institutional, and residential related building projects.

The Role We Want You For

The Quality Control Managerwill be involved in the implementation, oversight, and management of all aspects of Quality Control program, the management and coordination of all documentation performed by testing personnel and any other inspection personnel required by contract, within the Life Sciences/Biotech/Pharmaceuticals sector. The role includes direct oversight and review of the entire documentation and physical inspection phase of the workflow process and working with other in-house personnel to include Project Managers, Superintendents, and external personnel to produce and document a quality product.

The Specifics of the Role

• Coordinate, document, and track preparatory, initial, and follow-up inspections.
• Chair, plan and schedule the weekly QC meetings with the superintendent and provide written reports as described Provide daily QC reports that reinforce activities that are being constructed in conformance with each specific project's established standard.
• Collaborate with the project team to develop and establish the Quality Program.
• Provide ongoing status updates to executive management with recommendations for dealing with substandard performance and overall progress on quality goals.
• Manage and support respective quality teams in implementing the quality program.
• Identify the appropriate standards and procedure to be used for a specific task.
• Communication to the Enterprise regarding best practices, lessons learned, recent events and training opportunities.
• Drive implementation of the Quality Program on projects, focusing on core programs including Site Specific Quality Plans, policies, and procedures on project through proactive planning, training, support and sharing lessons learned.
• Manage verification and documentation is being done for all materials received for the project are in conformance with the approved submittal, are handled and stored appropriately and are acceptable for use in the project.
• Be involved with pre-construction meetings with new and existing subcontractors and the superintendent prior to the start of each new phase of the work to discuss issues that affect quality.
• Track construction deficiencies and ensure timely implementation of, and verify, all approved corrective actions.
• Help coordinate and document the testing and commissioning of building systems, review results, and submit.
• Assist project team to ensure subcontractor compliance to Project Site Specific Safety Plan and perform safety inspections and audits as required by Company practices.
• Skilled at maintaining and documenting conformance to developed quality plan.
• Able to monitor/manage deficiencies to quality plan and work to completion.
• Understands and monitors testing and inspection process. Maintains a positive relationship with those agencies.
• Able to identify the accuracy of subcontractor work.
• Understand inspection requirements by city, county, and state to receive TCO & CO.

Requirements

• Bachelor’s Degree in Industrial Engineering, Industrial Technology, Construction Management, or related degree, or relevant work experience considered in lieu of education.
• 5-15 years of progressive experience in construction, demonstrating increasing responsibility and expertise over time.
• Strong analytical and problem-solving skills with attention to detail.
• Ability to walk a job site and climb ladders.

Some Things You Should Know

• Our clients and projects are nationwide – Travel will be required.
• No other builder can offer the collaborative design-build approach that Clayco does.
• We work on creative, complex, award-winning, high-profile jobs.
• The pace is fast!
• This position is classified as a safety-sensitive role in accordance with applicable state and federal laws. Candidates selected for this position will be subject to a comprehensive background check, which includes mandatory drug testing.

Why Clayco?

• Best Places to Work – St. Louis Business Journal, Los Angeles Business Journal, Phoenix Business Journal.
• ENR – Top Midwest Contractors (#1), Top Design Build Contractors (#4), Top 400 Contractors (#20), ENR – Top Green Builders (#5).

Benefits

• Discretionary Annual Bonus: Subject to company and individual performance.
• Comprehensive Benefits Package Including: Medical, dental and vision plans, 401k, generous PTO and paid company holidays, employee assistance program, flexible spending accounts, life insurance, disability coverage, learning & development programs and more!

Compensation

• The salary range for this position considers a wide range of factors in making compensation decisions including but not limited to: Education, qualifications, skills, training, experience, certifications, internal equity, and location. Compensation decisions are dependent on the facts and circumstances of each case.

General Description:

Supervises staff and executes QC Biochemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, processes and procedures. Establishes and implements QC Biochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the Biochemistry laboratory.

Essential Functions of the job:

• Lead the QC Biochemistry GMP laboratory through late phase activities.
• Oversee QC Biochemistry laboratory related quality systems to ensure conformance with regulations and quality standards.
• Supervise a highly efficient QC Biochemistry team. Identify and develop key talents.
• Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and, scheduling, etc.
• Execute laboratory bench work for analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as required.
• Ensure Biochemistry laboratory compliance with Environmental Health and Safety (EHS) standards.
• Ensure timely completion of testing (e.g., in-process, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results In support of manufacturing operations.
• Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures.
• Implementation of effective corrective actions and preventive actions (CAPAs).
• Participate in internal and external GMP audits where possible.
• Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports.
• Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.
• Manage, motivate, coach and mentor direct reports.
• Undertake any other duties as required.

Core Competencies, Knowledge, and Skill Requirements:

• Scientific degree (ideally in Biochemistry, molecular biology, biotechnology or related).
• Minimum of 5-7 years working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required.
• Working knowledge and experience with Biochemistry analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as well as instruments such Incubators, Biosafety Cabinets, Plate Washers, and Microplate Readers, etc.
• Knowledgeable with USP/EP and cGMP/EU GMP regulations.
• Direct experience in a GMP quality control lab is a must.
• Familiar with instrument and equipment validation.
• Expert knowledge of quality control principles, practices, and standards for the biopharmaceutical industry.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Excellent project management skills.
• Hands-on approach, with a ‘can do’ attitude.
• Ability to prioritize, demonstrating good time management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development.

Supervisory Responsibilities:

• Supervise a highly efficient QC Biochemistry team. Identify and develop key talents.
• Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and scheduling, etc.
• Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports.
• Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.
• Manage, motivate, coach and mentor direct reports.

Industry: Pharmaceuticals

Title: Quality Control Analyst III

Job ID: NORT000022

Location: Norton, MA

Duration: 10 months contract (+Possibility of extension)

This position is onsite and will be primarily located in Norton, MA. There may be occasional responsibilities at a secondary location in Cambridge, MA.

Overview

The Quality Control Operations (QCO) LEQ Analyst III plays a crucial role in supporting the department's efforts to maintain the highest standards of quality and compliance from development through to commercialization. This position is responsible for supporting and executing laboratory equipment qualification activities in compliance with USP and applicable regulatory requirements. This role ensures laboratory instruments are fit for intended use throughout their lifecycle and supports data integrity, compliance, and continuous improvement within the laboratory quality system. By ensuring these critical activities are executed with precision, the LEQ Analyst III significantly contributes to routine laboratory operations, thereby enhancing the overall efficiency and effectiveness of the QC functions .

Key Responsibilities (including but not limited to):

• Perform and support laboratory equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in accordance with USP .
• Classify laboratory instruments (Groups A, B, and C) and determine appropriate qualification strategies.
• Review and approve qualification protocols, test scripts, and reports.
• Support equipment lifecycle management, including calibration, maintenance, requalification, and change control.
• Review vendor documentation (URS, manuals, certificates) to support qualification and compliance.
• Investigate and document deviations, discrepancies, and out-of-tolerance events related to equipment performance.
• Ensure qualification activities comply with internal SOPs, cGMP, data integrity principles, and regulatory expectations (e.g., FDA, EMA).
• Collaborate with laboratory staff, quality assurance, validation, facilities, and vendors to resolve equipment-related issues.
• Maintain accurate and complete documentation in electronic quality systems.
• Support audits and inspections by providing qualification documentation and technical explanations as needed.
• Adhere to internal standards, policies, and SOPs, as well as regulatory and industry standards (e.g., GMP, GLP, ICH guidelines) to maintain the highest levels of quality and compliance.
• Actively participate in continuous improvement efforts by identifying and suggesting enhancements to laboratory processes, particularly those related to efficiency and reliability.
• Actively participate in continuous improvement initiatives aimed at enhancing QC processes and procedures, increasing laboratory efficiency and effectiveness.

Qualifications

• B.S. in chemistry, biology, or biochemistry, or related scientific field ;
• Pharmaceutical/Biotech industry experience with 6-10 years in a GMP Quality Control function or equivalent, relevant industry experience
• Hands-on experience with laboratory equipment qualification in a regulated environment.
• Strong working knowledge of USP and laboratory instrument lifecycle management.
• Familiarity with cGMP, GLP, and data integrity requirements.
• Experience with common laboratory instruments (e.g., HPLC, GC, balances, dissolution, UV/Vis, pH meters, spectrometers).
• Ability to write clear, compliant technical documentation.
• Strong organizational skills with the ability to manage multiple tasks simultaneously and autonomously
• Excellent communication and teamwork abilities, capable of working effectively in a collaborative environment
• Experience in pharmaceutical, biotech, or contract testing laboratory environments.
• Exposure to computerized systems validation (CSV) as it relates to laboratory instruments.
• Familiarity with calibration and maintenance programs.
• Experience supporting regulatory inspections or internal audits.